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Redondo MJ et al. 12-OR. Presented at: American Diabetes Association Scientific Sessions, April 25-29 June 2021 (virtual meeting).
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Redondo reports that she is on an advisory board for Protection Bio. Please refer to the executive summary for all relevant financial information from the other authors.
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Daily oral insulin therapy can improve glucose and C-peptide readings in a subset of children at high risk for type 1 diabetes, according to new TrialNet data presented at the American Diabetes Association’s Scientific Sessions.
Maria Jose Redondo placeholder image
“The main message is that in the subgroup of participants with the highest risk of type 1 diabetes, either of the two oral doses of insulin that our study tested prevented metabolic indexes from deteriorating.” Maria Jose Redondo, MD, PhD, MPH, Associate Professor of Pediatrics, Diabetes and Endocrinology at Texas Children’s Hospital and Baylor College of Medicine, said Healio. “In a previous analysis, we had shown that this dose also produced beneficial immunological changes. At the other dose, neither the immunological nor the metabolic effects were observed. “
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As Healio previously reported, TrialNet data published in JAMA in 2017 showed that the risk of developing type 1 diabetes in autoantibody-positive relatives of patients with type 1 diabetes who were randomly assigned to oral insulin was not decreased and oral insulin did not delay the time to diabetes progression. The annualized diabetes rate in the main study group did not differ significantly between the participants who were assigned oral insulin (8.8%) or placebo (10.2%). However, the annualized rate of diabetes was lower in secondary groups receiving oral insulin with different autoantibody profiles and combinations of the thresholds for insulin release of the first phase; the median time to diabetes for this subgroup was also longer in the oral insulin group (55.3 months) than in the placebo group (24.3 months).
The researchers also observed a decrease in insulin autoantibody titers associated with an increase in islet-specific CD4 + T-cell frequencies in a subset of participants who received a daily oral dose of 67.5 mg of insulin, but not participants who received an oral insulin dose of 500 mg every 2 mg received weeks.
“Here we compared the two arms to assess whether metabolic effects also occur in the treatment arm with 67.5 mg per day,” said Redondo during a presentation.
The researchers analyzed data from children 3 to 16 years of age with autoantibody positivity and a Diabetes Prevention Trial Risk Score (DPTRS) of at least 6.75, a subgroup that has been shown to have metabolic effects of oral insulin (mean age 6 years ). Participants received 67.5 mg oral insulin (n = 13), 500 mg oral insulin twice a week (n = 17), or placebo daily for 6 months. Researchers measured changes in mean glucose and C-peptide response curves during an oral glucose tolerance test at baseline and after 6 and 12 months.
The researchers found that compared to baseline measurements, glucose levels were higher and C-peptide levels were lower for each OGTT time point (30 to 120 minutes) after 12 months for the 500 mg biweekly dose group. No metabolic deterioration was observed in the 67.5 mg daily dose group.
In a summary, the researchers wrote that the C-peptide to glucose ratio of the centroid coordinates changed little in the 67.5 mg daily dose group, but changed little in the 500 mg daily dose group (1.03 vs. -4.39; p <.05) after adjustment, decreased for baseline ratio, age and BMI-z-score.
“The better metabolic outcome of 67.5 mg oral insulin than 500 mg every 2 weeks is in line with the previous finding that immunological changes are associated with a daily dose of 67.5 mg, suggesting a link between immune and metabolic effects “write the researchers.
Redondo said some might be surprised that oral insulin benefits were seen in the participants at highest risk for type 1 diabetes as measured by DPTRS.
“The DPTRS includes C-peptide levels, glucose levels, BMI and age; A high DPTRS is associated with a high risk of progression to type 1 diabetes, ”Redondo told Healio. “Our observation is surprising because it was previously believed that it would be easier to stop or reverse the autoimmune attack on beta cells when this process is less advanced.”
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